Jackson G, Martin E, McGing E, et al. Successful withdrawal of oral long-acting nitrates to facilitate phosphodiesterase type 5 inhibitor use in stable coronary disease patients with erectile dysfunction. Journal of Sexual Medicine, 2005:513-16
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/16422846
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 55 enrolled
Age: 65.2 years (range 44 to 81 years) Sex: 0 female, 55 male Participants with dementia: No Inclusion criteria: · Long-acting oral nitrates as well as carrying sublingual nitrates · Clinically stable Ischemic patients with no significant exercise limitation · Using sublingual nitrates less than once a month Exclusion criteria: · None stated Concomitant medicines: beta-blockade or calcium antagonist therapy Country: England Setting: Community -patients at a clinic dedicated to giving sexual advice to men with cardiac disease and erectile dysfunction. |
| Interventions | Medicine: nitrates
Withdrawal schedule: Halved the nitrate dose for two days then discontinue if no increase in symptoms occurred |
| Outcomes | Successful deprescribing
Exacerbation of angina Five-item Sexual Health Inventory for Men (SHIM) |
| Dates | Dates: Not stated
Follow-up duration: Three months |
| Funding sources | Not described |
| Notes | Deprescribing was not the only intervention:
“Those not taking any current evidence-based optimal therapy (aspirin, beta-blockade, angiotensin-converting-enzyme-inhibitors, and statins) were asked to consult with their referring physician for clarification and advice.” This study considered the half-life of the drug in making decisions about trial methodology. Authors statement: “Conflict of Interest: None.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Not randomized. |
| Allocation concealment (selection bias) | High risk | It was an open study. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | It was an open study. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | As above. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | There appears to be 100% follow-up, and all data reported. |
| Selective reporting (reporting bias) | 2 out of 5 | There is no evidence of a pre-specified protocol and analysis plan. However, the stated objectives are reported. |
| Confounding (non-randomized) | 5 out of 5 | There was no concurrent control group. |
| Other bias | High risk | Deprescribing was not the only intervention:
“Those not taking any current evidence-based optimal therapy (aspirin, beta-blockade, angiotensin-converting-enzyme-inhibitors, and statins) [5] were asked to consult with their referring physician for clarification and advice.” Other comments: This study considered the half-life of the drug in making decisions about study methodology. This is unusual, and a strong aspect of this study. |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | The intervention cohort was somewhat representative of the average older male with comorbid cardiovascular disease and erectile dysfunction. |
| Selection of the non-exposed cohort | There was no concurrent control group.
|
|
| Ascertainment of exposure | Ascertainment of exposure was through secure record. | |
| Demonstration that outcome of interest was not present at start of study | The researchers demonstrated that outcome of interest was not present at start of study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controls for nitrate cessation. |
| Outcome bias | Assessment of outcome | Outcomes were assessed by self-report. |
| Was follow-up long enough for outcomes to occur | Follow-up appeared to be of sufficient duration for the outcomes of interest to occur. However, a longer duration would have been preferable if it were strictly a deprescribing trial. However, they wanted to continue on to phase 2 of the study and commence phosphodiesterase type 5 inhibitors therapy | |
| Adequacy of follow-up of cohorts | Complete follow-up – all subjects accounted for. | |
Leave a Reply